overview of veternary drug products

1. An Updates On Veterinary
Formulations
Presented By:
Parimal Hadge
PE/2019/311
Sub: PE-620
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2. Contents
• Introduction
• Drug Delivery Systems in Veterinary Medicine
• Veterinary dosage forms
• Marketed Preparation
• Updates
• Latest drugs approved by FDA
• Conclusion
• References
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3. Introduction
Veterinary medicine is the branch of medicine that deals with the
prevention, diagnosis and treatment of disease, disorder and injury in
non-human animals.
Importance of new drugs in veterinary medicine
Companion animals
In many countries with aging populations, humans are increasingly
seeking animal companionship and companion animals are now more
likely to be considered as members of the family than they were previously.
Food-producing animals
According to the Food and Agricultural Organization ( FAO ), the
world’s population will surpass 9 billion by the year 2050. A substantial
part of the increased population will be relatively wealthy, and it is
estimated that the annual meat production will need to almost double to
470 million tons to meet the demand.
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4. Drug Delivery Systems (DDS) in veterinary
medicine
• One obvious problem is the delivery of orally active
drugs to ruminants. Drugs that bypass the rumen for
absorption in the intestines are sometimes desirable.
Alternatively, some drugs may be encapsulated in
liposomes that may protect the drug from degrading
enzymes. Transdermal administration of liposome-
encapsulated drugs is also possible.
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Based on observations that the folate receptor (FR) is widely expressed in human
cancer, researchers at Purdue University in the United States examined expression of
FR in canine cancers and developed a FR-targeting form of DDS for vinblastine. One of
the problems with this system is the development of a reliable means to measure FR
expression on canine cancers in vivo.

5. Veterinary Dosage Forms
Special Formulations
Allergens
specific
therapies
Campylobacter
vaccines
Multivalent
vaccine
Pain treatment
Cancer
treatment
Biotechnology
• Tablets and Boluses
• Capsules
• Food Additives
• Drinking Water Medications
• Parenteral Dosage Forms
• Oral Paste and Gels
• Drenches and Tubing Products
• Topical Dosage Forms
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6. Dose
Drugs are given on the basis of body weight of the animal or body
surface area of the animal.
Example-
15 g of of drug for each 150 kg body weight.
75 g of drug for each 750 kg body weight of cow or horses.
A special tablet called a ‘Bolus’ is commonly used these large dosage. A
bolus nothing more than a very large tablet which can range from 3 to
16 g or more.
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7. Feed Additives
• Feed additives are preparations used in veterinary medicines to deliver the API
via water or food given to the animals, also called premix.
• There are three types –
• A) Medicated articles (one or more API sold to licensed feed mill diluted with
water and consumed)
• B) Medicated feed ( type A medicated articles + nutrients not less than 25% of
total body weight).
• C) Medicated feed ( compressed or molded box + nutrients + food and
consumed)
Drinking Water Medication
A) Dry powder- Dry powder reconstituted into liquid and then mix into drinking
water.)
b) Concentrated Solution – Dispensed directly into drinking water in medical
preparation.
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8. Parenteral Dosage Forms
• Injectables (Solutions, Suspension, Emulsion, Dry powder)
• Intra-vaginal delivery system (For lactating or non-lactating cow)
• Intra mammary infusion (Poly-urethane sponge, containing synthetic
progestin)
• Implants (Compressed tablets, Dispersed matrix system with polymer)
•Drenches and Tubing Products
• Liquid Drenching gun or Powder Drenching gun are used .
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9. Marketed Preparations and Devices
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Polyurethane sponge
containing progestin
Liquid drench gun Powder drench gun
Tubing
Intra mammary
infusion

10. Marketed Preparation
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Used for gastric Ulcer Treatment Skin Diseases
Ivermectin Drench Antihelmintic Tablets Drinking Water additives
Treatment of dogs with
hyperadrenocorticism

11. Special Formulations
Practical applications of veterinary pharmaceuticals may require a
degree of innovation for application in in the field. For example it may
be difficult to maintain a cold chain in certain hot countries and new
methods for the delivery of heat sensitive pharmaceuticals need to be
developed. Such innovation method include effervescent tablets for
Newcastle disease, vaccines in poultry and freeze dried highly soluble
spheres also for poultry that may be dissolved for use in drinking water.
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12. Updates
FDA’s Center for Veterinary Medicine (CVM) issues CVM Updates on topics of
interest to our stakeholders. These brief news releases provide the public with
relevant and timely information about FDA and animal health.
1. FDA Conditionally Approves First Oral Tablet to Treat Lymphoma
in Dogs
United States Food and Drug Administration conditionally approved Laverdia-
CA1 (Verdinexor tablets) to treat dogs with lymphoma, a type of cancer of the
lymph nodes and lymphatic system. Laverdia-CA1 works to prevent certain
proteins from leaving the nucleus of cancer cells, thereby allowing these
proteins to control the growth and prevent the spread of cancerous cells in
dog’s.
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13. 2. FDA Approves First Intra-tumoral Injection to Treat Non-
Metastatic Mast Cell Tumors in Dogs
• Food and Drug Administration approved STELFONTA (TIGILANOL
TIGLATE INJECTION) to treat dogs with non-metastatic, skin-based
(cutaneous) mast cell tumors (MCTs). The FDA is also approving
STELFONTA to treat non-metastatic MCTs located under the dog’s
skin (subcutaneous), in particular areas of a dog’s leg. STELFONTA is
injected directly into the MCT (Intratumoral Injection). STELFONTA
works by activating a protein that spreads throughout the treated
tumor, which disintegrates tumor cells.
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14. 3. FDA Approves CLEVOR (Ropinirole Ophthalmic Solution) to
Induce Vomiting in Dogs
• The U.S. Food and Drug Administration’s Center for Veterinary
Medicine has approved CLEVOR (ropinirole ophthalmic solution) for
inducing vomiting in dogs. CLEVOR is a dopamine agonist that is
administered by drops in the dog’s eye.
Animal Drug Product Regulation Process
• Involve two processes
1) Investigational New Animal Drug ( INAD )
2) New Animal Drug Application ( NADA )
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15. Recent Animal Drug Approvals
Date Application number Product name Species
Dec 16 2020 ANADA 200-696 SelaSpot ™ Dogs and Cats
Nov 25 2020 ANADA 200-557 Tzed ™ Dogs
Nov 16 2020 NADA 141-541 STELFONTA® Dog
Oct 29 2020 ANADA 200-692 CYCLAVANCE™ Cat
Oct 16 2020 NADA 141-536 Elura™ Broiler, roaster, and replacement (breeder and layer)
chickens, and quail
Sep 29 2020 ANADA 200-692 Savalan® 60 Lactating dairy cows and beef cows
Sep 28 2020 ANADA 200-069 OvaCyst® Broiler and replacement chickens and growing turkeys
Sep 18 2020 ANADA 200-690 ZoaShield™ 25% vBroiler chickens
Sep 9 2020 NADA 141-529 Pennitracin MD ® and Maxiban ™ Dog
Aug 4 2020 ANADA 200-681 Carprofen Tablets Dog
July 29 2020 ANADA 200-687 Carprofen Chewable Tablets Dog
July 27 2020 NADA 141-538 Cardalis ™ Dog
July 9 2020 NADA 141-532 BRAVECTO® 1-MONTH Cats and Dogs
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16. Conclusion
• The Animal Health market represents an area of the pharmaceutical
industry that is smaller, has less total resources spent on it and offers
less rewards compared to its human counterpart.
• The industry faces many issues, not the least of which is that
currently there is a lack of new APIs appearing on the veterinary
market.
• Overall, therefore, studying veterinary drug delivery as an area of
research within an academic environment opens up the opportunity
to investigate a wider range of possibilities and propose a greater
number of solutions compared to an industry based researcher
focused on getting a formulation approved.
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17. References
• Shradha Tiwari, Sachin Mitkare, Pallavi Bhangale ; Veterinary Dosage
• Forms: International Journal of Applied Pharmaceutics, ISSN 0975-7058,
Vol-6, Issue 1,2014. P.20-29
• Ramteke KH, Joshi SA, Dighe PA and Kharat AR; Veterinary
Pharmaceutical Dosage Forms: A Technical Note, Austin Publishing
Group, Austin Therapeutics, ISSN-2472-3673,Vol-1,Issue 1,2014. P.1-10
• Product List Updated www.VOHC.org
• Veterinary Dosage Forms; In Encyclopedia of Pharmaceutical Technology;
Edited by J. Swarbrick and J. Boylan; Marcel Dekker INC; second edition;
vol-3; pp- 2932.
• .“New Advances in Technology for Pets,” Veterinary Medicine and
Biomedical Sciences, Texas A&M
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